AB0917 A RANDOMIZED CONTROLLED PROSPECTIVE SINGLE-CENTER FEASIBILITY STUDY OF RHEOPHERESIS FOR RAYNAUD’S SYNDROME AND DIGITAL ULCERS IN SYSTEMIC SCLEROSIS (RHEACT) - PRESENTATION OF FIRST INTERIM RESULTS
Authors: J. G. Rademacher, V. Korendovych, A. Borisch, T. Asendorf, P. Korsten
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Raynaud's phenomenon (RP) and digital ulcers (DU) are frequent manifestations of Systemic Sclerosis (SSc). There are very few available approved drugs with varying efficacy. Rheopheresis (RheoP) is an extracorporeal apheresis technique used to treat microcirculatory disorders by improving blood viscosity. The effect of RheoP in SSc is currently unknown, and here, we report the interim results of the first patients. <h3>Objectives</h3> To determine the efficacy of RheoP compared to Standard of Care (SoC) intravenous iloprost on RCS and DU healing. <h3>Methods</h3> A <i>randomized controlled prospective single-center feasibility study of Rheopheresis for Raynaud's syndrome and Digital Ulcers in Systemic Sclerosis (RHEACT</i>) aims to investigate the efficacy of RheoP on the Raynaud Condition Score (RCS) as the primary outcome measure after 16 weeks from baseline. A planned number of 30 patients will be randomized in a 1:1:1 ratio to one of two RheoP treatment groups or assigned to the SoC control group. <h3>Results</h3> We here report the results of the first seven patients. The patient assigned to the RheoP1 group had a baseline Raynaud Condition Score (RCS of 8, which improved to 0 after 16 weeks (the primary endpoint). The two patients randomized to the RheoP2 had a baseline RCS of 8 and 6, respectively, which improved to 4 and stayed unchanged at 6 in the second patient. The four patients assigned to SoC had only minimal improvement. RheoP1 had a significantly lower RCS compared to RheoP2 and SoC at week 16 (*p&lt;0.05). Furthermore, DU completely healed in patients with DU at baseline with either RheoP therapy and avoided amputation in one patient. Exemplary images are shown in figure 2 (A, baseline; B, at week 16). <h3>Conclusion</h3> RheoP improved the RCS and DU better than SoC (Iloprost) treatment alone and avoided amputation in one patient. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Jan-Gerd Rademacher Grant/research support from: This investigator initiates trial was funded by Diamed Medizintechnik GmbH. The sponsor had no role in the design, conduction, or data analysis., Viktor Korendovych Grant/research support from: This investigator initiates trial was funded by Diamed Medizintechnik GmbH. The sponsor had no role in the design, conduction, or data analysis., Angela Borisch Grant/research support from: This investigator initiates trial was funded by Diamed Medizintechnik GmbH. The sponsor had no role in the design, conduction, or data analysis., Thomas Asendorf Grant/research support from: This investigator initiates trial was funded by Diamed Medizintechnik GmbH. The sponsor had no role in the design, conduction, or data analysis., PETER KORSTEN Grant/research support from: This investigator initiates trial was funded by Diamed Medizintechnik GmbH. The sponsor had no role in the design, conduction, or data analysis.